RecruitingPhase 1

A Study of ARC-02 in B-cell NHL

United States, Australia, France140 participantsStarted 2026-06-22

Plain-language summary

This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. A documented diagnosis of B-cell Non- Hodgkin Lymphoma (NHL) per 2016 World Health Organization criteria and disease requiring treatment:
. Follicular lymphoma (FL), Grades 1 through 3B
. Marginal zone lymphoma (MZL)
. Mantle cell lymphoma (MCL)
. Diffuse large B-cell lymphoma (DLBCL)
. Other B-cell NHL
. Measurable disease.
. Received at least 2 prior lines of systemic therapies and not eligible to receive additional standard of care therapies.

Exclusion criteria

. Receiving an investigational product or participating in any other type of medical research judged not to be compatible with this study.
. Grade \> 1 neuropathy
. History of interstitial lung disease (ILD)/pneumonitis requiring treatment or any evidence of active ILD/pneumonitis.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dose Escalation: Number of Participants with Dose-Limiting Toxicities (DLTs)

Timeframe: Up to 5 years

Dose Escalation: Number of Participants with Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Timeframe: Up to 5 years

Dose Expansion: Objective Response Rate (ORR) as Assessed by the Investigator

Timeframe: Up to 5 years

Trial details

NCT IDNCT07691606

SponsorTaiho Oncology, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-01

Contact for this trial

Taiho Oncology, Inc.

+1 844-878-2446 ABLATE-101@taihooncology.com

View on ClinicalTrials.gov More B-cell Non Hodgkin Lymphoma trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. A documented diagnosis of B-cell Non- Hodgkin Lymphoma (NHL) per 2016 World Health Organization criteria and disease requiring treatment:
. Follicular lymphoma (FL), Grades 1 through 3B
. Marginal zone lymphoma (MZL)
. Mantle cell lymphoma (MCL)
. Diffuse large B-cell lymphoma (DLBCL)
. Other B-cell NHL
. Measurable disease.
. Received at least 2 prior lines of systemic therapies and not eligible to receive additional standard of care therapies.

Exclusion criteria

. Receiving an investigational product or participating in any other type of medical research judged not to be compatible with this study.
. Grade \> 1 neuropathy
. History of interstitial lung disease (ILD)/pneumonitis requiring treatment or any evidence of active ILD/pneumonitis.

What they're measuring

Dose Escalation: Number of Participants with Dose-Limiting Toxicities (DLTs)

Timeframe: Up to 5 years

Dose Escalation: Number of Participants with Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Timeframe: Up to 5 years

Dose Expansion: Objective Response Rate (ORR) as Assessed by the Investigator

Timeframe: Up to 5 years